NCT06294015

Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops. Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment. The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates. The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue.

Conditions

• Corneal Epitheliopathy
• Glaucoma
• Corneal Disease
• Dry Eye

Interventions

Type	Name	Description
BIOLOGICAL	20% ASED + AT	Participants receive 20% Autologous Serum Eye Drops prepared by the hospital laboratory from the patients blood, diluted with sterile 0.9% sodium chloride to achieve the desired concentration. These drops are administered 6 times daily in one eye for two months. On top of this intervention is standard artificial tears therapy (Refresh Plus), applied four times daily.
DRUG	0.9% NS + AT	Participants in the placebo group receive eye drops consisting of sterile 0.9% sodium chloride solution, which serves as the placebo. The placebo solution is administered 6 times daily in one eye for two months. Alongside the placebo drops, participants continue with standard artificial tears therapy (Refresh Plus), applied four times daily throughout the study duration.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2024-03-05
• Last updated: 2024-03-05